FDA product code QBI: Acute Coronary Syndrome Event Detector
QBI is the FDA product code for acute coronary syndrome event detector. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QBI reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for QBI devices, 1 initiated in the last five years.
Definition
Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
Classification
| Field | Value |
|---|---|
| Device name | Acute Coronary Syndrome Event Detector |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QBI devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-01.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code QBI?
QBI is the FDA product code for acute coronary syndrome event detector. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QBI?
Class III. Typical premarket route: PMA.
Have QBI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-09-01.
Next steps
- Run an FDA pathway report with predicate devices for product code QBI
- Run a recall and safety report across every QBI manufacturer
- Watch product code QBI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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